CQA

Job Description : CQA IRELAND Open to International candidates with 20+ years experience Candidate must have major experience in Sterile Pharmaceutical Manufacturing Plants. - Must have been working in Corporate Quality Assurance (CQA) for the last 3–4 years minimum. - Candidates with strong leadership experience in SVP, LVP, injectable, and lyophilized manufacturing facilities will be preferred. ???? Key Job Responsibilities 1. Corporate Quality Leadership: Lead and oversee CQA functions across sterile manufacturing facilities, ensuring consistent implementation of corporate quality policies and procedures. 2. Quality Management Systems (QMS): Establish, review, and strengthen corporate quality systems, including deviations, CAPA, change control, OOS/OOT, investigations, and risk management. 3. Regulatory Compliance: Ensure compliance with applicable WHO-GMP, USFDA, EU-GMP, MHRA, and other relevant regulatory requirements, as applicable to the company's markets. 4. Audit & Inspection Management: Lead regulatory inspections, customer audits, internal audits, mock inspections, and timely closure of audit observations. 5. Sterile Manufacturing Quality Oversight: Ensure effective quality governance for aseptic processing, contamination control, environmental monitoring, sterilization, media fills, and sterility assurance. 6. Data Integrity & Documentation: Ensure ALCOA+ principles, good documentation practices, data integrity, and robust review of quality records across manufacturing sites. 7. Validation & Qualification Oversight: Provide corporate oversight for process validation, cleaning validation, sterilization validation, aseptic process simulation, and qualification activities. 8. Quality Risk Management: Identify critical quality risks, implement preventive strategies, and drive continuous improvement across sterile manufacturing operations. 9. Cross-Functional Coordination: Work closely with Plant QA, QC, Production, Engineering, Microbiology, Regulatory Affairs, and senior management to maintain quality standards. 10. Team Leadership & Development: Lead CQA teams, mentor site quality leaders, establish quality KPIs, and drive a strong quality culture across the organization. 11. Product Quality & Compliance: Oversee product quality reviews, complaint investigations, recalls, and effectiveness checks for CAPA implementation.

---